PMA
P160049: STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON
FDA PMA · Drug-Eluting Peripheral Transluminal Angioplasty Catheter · The Spectranetics Corp.
Key facts
| PMA number | P160049 |
|---|---|
| Trade name | STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON |
| Generic name | Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
| Applicant | The Spectranetics Corp. |
| Owner/operator | Philips Medical Systems International BV |
| Product code | ONU |
| Approval date | Jul 26, 2017 |
| Docket number | 17M-4498 |
| Notice date | Jul 28, 2017 |
| Establishment registration | 2939520 |
| FEI number | 2939520 |
At a glance
- 10–99 Supplements
- Mar 19, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 100–999 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: